- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05929131
Video and Brochure and Discharge Instructions for Childhood Fever in the Pediatric Emergency Department
September 3, 2023 updated by: Aylin Kurt, Bartın Unıversity
This study was designed to evaluate whether adding Video discharge instructions to usual verbal information improves understanding of the information provided to caregivers of patients presenting to pediatric emergency departments for high fever.
As secondary goals, it was aimed to assess whether video discharge instructions increase satisfaction with information received and reduce repeat visits.
Study Overview
Status
Completed
Conditions
Detailed Description
The research will be carried out in a randomized controlled manner.
There will be three groups in the research: those who received video (intervention), brochure (intervention) and verbal (control) discharge instructions.
A power analysis was performed based on the number of children in both groups, in another study in which the scales to be used in the research were used.
According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 48 cases in each group would be sufficient for 80% power.
Children who meet the research criteria will be assigned a random number to the intervention and control groups via http://www.randomize.org/ by numbering the order of arrival at the hospital.
Research data will be collected using Descriptive Information Form and Parental Fever Management Scale and Post-Discharge Data Collection Form.
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bartın, Turkey, 74100
- Bartin Maternity and Pediatrics Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- The child is between 1 month and 18 years old
- Parent's consent to participate in the research
- Parent's completion of all pre-and post-education follow-up
Exclusion Criteria:
- The child is not between 1 month and 18 years old
- The child does not undergo day surgery.
- Parent's refusal to participate in the research
- Parent not completing all pre- and post-education follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: discharge instructions with video
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups.
Before parents in the control group are discharged from the pediatric emergency service, a short 2-minute video will be shown to the American Academy of Pediatrics (2020) guidelines (intervention group with video) giving the same information about high fever to patients in addition to the verbal instructions.
Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups.
All patients will also receive a discharge report with instructions on post-treatment treatment.
|
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups.
Before parents in the control group are discharged from the pediatric emergency service, a short 2-minute video will be shown to the American Academy of Pediatrics (2020) guidelines (intervention group with video) giving the same information about high fever to patients in addition to the verbal instructions.
Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups.
All patients will also receive a discharge report with instructions on post-treatment treatment.
|
Placebo Comparator: verbal discharge instructions only
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups.
Parents in the control group will receive the usual verbal information and advice on high fever management in accordance with the guidelines of the American Academy of Pediatrics (2020) prior to discharge from the pediatric emergency service.
Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups.
All patients will also receive a discharge report with instructions on post-treatment treatment.
|
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups.
Parents in the control group will receive the usual verbal information and advice on high fever management in accordance with the guidelines of the American Academy of Pediatrics (2020) prior to discharge from the pediatric emergency service.
Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups.
All patients will also receive a discharge report with instructions on post-treatment treatment.
|
Experimental: discharge instructions with pamphlet
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups.
Before the parents in the control group are discharged from the pediatric emergency service, in the second group (intervention group with brochure) in accordance with the guidelines of the American Academy of Pediatrics (2020), the parents will be told with the brochure giving the same information about fever in addition to the verbal instructions.
Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups.
All patients will also receive a discharge report with instructions on post-treatment treatment.
|
Parents who agree to participate in the study will be randomly assigned to the control or intervention groups.
Before the parents in the control group are discharged from the pediatric emergency service, in the second group (intervention group with brochure) in accordance with the guidelines of the American Academy of Pediatrics (2020), the parents will be told with the brochure giving the same information about fever in addition to the verbal instructions.
Instructions will be given by the same researcher to provide homogeneous and consistent information in all three groups.
All patients will also receive a discharge report with instructions on post-treatment treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The parents in the groups who received discharge instructions with a video and brochure, three days later, had a lower "Parental Fever Management Scale" score average than the control group.
Time Frame: 3 days
|
As a result of the answers given to the scale, the total score varies between 8 and 40.
The increase in the total score of the scale indicates that parents developed high anxiety and fever phobia during the care of their children's febrile illnesses.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The parents in the groups who received discharge instructions with a video and brochure, after three days, had higher scores on the "Fever Management Approach Scale" compared to the control group.
Time Frame: 3 days
|
The scores that the participants can get vary between 6-36.
Evaluation is defined as the participants with a score below 21 approaching the fire with fear, while the participants with a score above 20 contribute to fever management in children with a functional approach.
Parents who receive discharge instructions with videos and brochures are expected to have an average score above 20.
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2023
Primary Completion (Actual)
August 30, 2023
Study Completion (Actual)
August 30, 2023
Study Registration Dates
First Submitted
June 4, 2023
First Submitted That Met QC Criteria
June 26, 2023
First Posted (Actual)
July 3, 2023
Study Record Updates
Last Update Posted (Actual)
September 6, 2023
Last Update Submitted That Met QC Criteria
September 3, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-SBB-0645
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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